Montrouge, France, March 2, 2023

DBV Applied sciences Experiences Full 12 months 2022 Monetary Outcomes and Enterprise Replace

• DBV accomplished EVOLVE, a 12-week caregiver and affected person person expertise research of the modified Viaskin Peanut patch in peanut-allergic kids ages 4 – 11 years outdated

• DBV had $209.2 million in Money and Money Equivalents at December 31, 2022.

DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, right now reported monetary outcomes for the total 12 months 2022. The audit procedures have been considerably accomplished by the Firm’s statutory auditors and financials – ready underneath each US GAAP and IFRS for the aim of Type 10-Okay and Common Registration Doc respectively – had been authorized by the Board of Administrators on March 2, 2023.

EVOLVE
DBV accomplished EVOLVE, a 12-week caregiver and affected person person expertise research of the modified Viaskin Peanut patch in 50 peanut allergic kids ages 4 – 11-years outdated.  The target of EVOLVE was to judge the Directions for Use (IFU) and ease of use for the modified Viaskin Peanut patch. The research concluded that the up to date Viaskin Peanut IFU supported appropriate patch utility, which included no lifting of the patch edges or detachment immediately after utility. Moreover, EVOLVE concluded that almost all of oldsters/caregivers reported a optimistic ease of use expertise with the modified Viaskin Peanut patch.

In EVOLVE, DBV additionally examined the performance of an digital affected person diary (eDiary) to gather data on actions of every day residing and patch adhesion scores.  As beforehand introduced, VITESSE will assess patch adhesion of the modified Viaskin Peanut patch and DBV will embody a statistical take a look at of adhesion within the VITESSE statistical evaluation plan.  EVOLVE verified that the eDiary instrument can be utilized by caregivers in VITESSE to seize the adhesion knowledge in assist of a possible BLA utility.

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Monetary Highlights for the Full 12 months 2022
The Firm’s annual consolidated monetary statements are ready in accordance with each usually accepted accounting rules within the U.S. (“US GAAP”) and Worldwide Monetary Reporting Requirements (“IFRS”) as adopted by the European Union. Except in any other case indicated, the monetary figures within the Full 12 months 2022 Monetary Highlights are introduced underneath each U.S GAAP and IFRS monetary statements, and commented utilizing U.S. GAAP monetary statements. Variations between US GAAP and IFRS consolidated monetary statements are primarily because of discrepancies arising from the appliance of lease accounting requirements.

Money and Cash Equivalents

Money and money equivalents quantity to $209,2 million as of December 31, 2022, in comparison with $77,3 million as of December 31, 2021, which is a rise by $131,9 million because of:

(1)   $194,1 million because of financing actions, primarily from ATM Program in Could 2022 ($14,1 million, web of transaction prices), then from personal funding in public fairness ($180,4 million, web of transaction prices);

(2)   $26,1 million reimbursed by French tax administration for analysis tax credit associated to years 2019, 2020, and 2021;

And partially offset by:

(3)   $81,8 million of money used for operations, earlier than $26,1 million reimbursement of analysis tax credit. It is a lower of 24% in comparison with prior 12 months reflecting the fee containment measures that has been constantly maintained since their implementation in 2020.

(4)   $6,5 million damaging influence of modifications in trade charges.

The Firm’s treasury place, acknowledged in US {Dollars}, has benefited within the final quarter from a change within the Euro to US Greenback trade charge. The corporate’s actions and expenditures within the fourth quarter had been in keeping with expectations and proceed to replicate DBV’s expense self-discipline.

Working Income

Working revenue quantities to $4,8 million as of December 31, 2022, in comparison with $5,7 million as of December 31, 2021, which is a lower by $0,9 million because of:

(1)   A lower in 2022 analysis tax credit score by $1.8 million in comparison with 2021 This replicate the influence of the worldwide restructuring plan initiated in 2020 and accomplished in 2021 which has impacted the bills eligible to the analysis tax credit score.

(2)   Partially offset by the variance in different working revenue that consists of revenues acknowledged prematurely of the completion of the collaboration settlement with Nestlé Well being Science (“NHS”).

Working Bills 

Working bills quantity to $101,5 million as of December 31, 2022, in comparison with $104,3 million as of December 31, 2021, which is a lower by $2,8 million primarily because of the lower in personnel bills because of the worldwide restructuring plan that was introduced in 2020 and accomplished in the midst of 2021. The common variety of workers was 86 for the 12 months ended December 31, 2022, in comparison with 101 and 270 for the years ended December 31, 2021 and 2020 respectively.

This discount in our working bills additionally displays the strict monetary self-discipline maintained throughout all providers to focus our sources on the assist of our scientific trial goals.

Web Loss and Web Loss per Share

Web consequence for the 12 months ended December 31, 2022, is a loss amounting to $96,3 million, in comparison with a loss amounting to $97,8 million for the 12 months ended December 31, 2021.

On a per share foundation, web loss (primarily based on the weighted common variety of shares excellent over the interval) is $1.24 for the 12 months ended December 31, 2022.

Convention Name Info

DBV will host a convention name and stay audio webcast right now, Thursday, March 2,
2023, at 5:00 p.m. ET to report fourth quarter 2022 monetary outcomes and supply a
enterprise replace.

Attendees might entry the decision through the beneath teleconferencing numbers and asking to affix the DBV Applied sciences name:

A stay webcast of the decision can be accessible on the Buyers & Media part of the Firm’s web site: https://www.dbv-technologies.com/investor-relations/ A replay of the presentation may also be accessible on DBV’s web site after the occasion

CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION

CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS

CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW

About DBV Applied sciences
DBV Applied sciences is growing Viaskin™, an investigational proprietary know-how platform with broad potential functions in immunotherapy. Viaskin relies on epicutaneous immunotherapy, or EPIT™, and is DBV Applied sciences’ technique of delivering biologically lively compounds to the immune system by way of intact pores and skin. With this new class of non-invasive product candidates, the Firm is devoted to securely reworking the care of meals allergic sufferers. DBV Applied sciences’ meals allergy symptoms applications embody ongoing scientific trials of Viaskin Peanut. DBV Applied sciences has international headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Firm’s abnormal shares are traded on phase B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing one-half of 1 abnormal share) are traded on the Nasdaq International Choose Market (Ticker: DBVT).

Ahead Trying Statements
This press launch might comprise forward-looking statements and estimates, together with statements relating to DBV’s forecast of its money runway, designs of DBV’s anticipated scientific trials, DBV’s deliberate regulatory and scientific efforts together with timing and outcomes of communications with regulatory businesses, the flexibility of any of DBV’s product candidates, if authorized, to enhance the lives of sufferers with meals allergy symptoms, and the end result of any litigation. These forward-looking statements and estimates will not be guarantees or ensures and contain substantial dangers and uncertainties. At this stage, DBV’s product candidates haven’t been licensed on the market in any nation. Among the many elements that would trigger precise outcomes to vary materially from these described or projected herein embody uncertainties related usually with analysis and growth, scientific trials and associated regulatory opinions and approvals, together with the influence of the COVID-19 pandemic, and DBV’s potential to efficiently execute on its finances self-discipline measures. An extra record and outline of dangers and uncertainties that would trigger precise outcomes to vary materially from these set forth within the forward-looking statements on this press launch might be present in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and stories with the U.S. Securities and Trade Fee (“SEC”), together with in DBV’s Annual Report on Type 10-Okay for the 12 months ended December 31, 2022, filed with the SEC on March 2, 2023, and future filings and stories made with the AMF and SEC by DBV. Present and potential traders are cautioned to not place undue reliance on these forward-looking statements and estimates, which converse solely as of the date hereof. Aside from as required by relevant regulation, DBV Applied sciences undertakes no obligation to replace or revise the knowledge contained on this Press Launch.

Investor Contact
Anne Pollak
DBV Applied sciences
+1 857-529-2363
[email protected]

Media Contact
Angela Marcucci
DBV Applied sciences
+1 646-842-2393

[email protected]

Viaskin and EPIT are logos of DBV Applied sciences.

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